Non-invasive Cardiac Output Monitoring in Obstetric Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by Massachusetts General Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Yandong Jiang, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01516697
First received: January 12, 2012
Last updated: August 2, 2012
Last verified: August 2012
  Purpose

The investigators hypothesize that continuously measuring stroke volume (SV) and cardiac output (CO) will 1) reveal hemodynamic instability in a timely manner and alert the physician promptly, 2) provide information for the physician to make the differential diagnosis as to whether the hemodynamic instability was due to vasodilatation or reduction of venous blood return, and 3) lead to appropriate and prompt treatment to improve patient outcome.

-determine the SV and CO and their kinetic change using ICON® to establish a hemodynamic profile of the patient under spinal anesthesia for cesarean section. To determine if using instantaneous measurements of SV and CO to guide patient management improves hemodynamic stability.


Condition Intervention Phase
Complications; Cesarean Section
Anesthesia; Adverse Effect, Spinal and Epidural
Procedure: experimental
Procedure: Control
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Using Thoracic Electrical Bioimpedance to Measure Stroke Volume and Cardiac Output in Patients Under Spinal Anesthesia for Cesarean Section

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Maximum percentage changes in mean blood pressure after spinal anesthesia [ Time Frame: baseline before spinal anesthesia and up to 20 minutes after spinal anesthesia ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: October 2011
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Control
The patients in Group A will serve as controls and will receive standard monitoring in addition to continuous measurement of SV and CO. The physicians will not know the CO and SV and will manage the patients in a standard fashion.
Procedure: Control
Data obtained from the non-invasive cardiac output monitor,ICON®, are not available for the anesthesia care providers.
Experimental: experimental
The patients in Group B will receive the same monitoring as those in Group A. But the physicians will know instantaneously the CO and SV in real time and will manage the patients accordingly.
Procedure: experimental
Non-invasive cardiac output monitoring using thoracic electric bioimpedance analysis via ICON® in addition of the standard monitoring during cesarean section.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age 18-45;
  • receiving spinal anesthesia or combined spinal and epidural anesthesia to undergo cesarean section

Exclusion Criteria:

  • Patients who have major cardiovascular disease,preexisting of hypertension or gestational hypertension, preeclampsia and body mass index greater than 35kg/m2;
  • Patients who have skin lesion at the place where the electrode is supposed to be applied;
  • Emergency cesarean section patients.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01516697

Contacts
Contact: Yandong Jiang, M.D., Ph.D. 617-447-9707 YJIANG@PARTNERS.ORG
Contact: Yanhong Liu, M.D., Ph.D. 617-724-4496 YLIU35@PARTNERS.ORG

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Yandong Jiang, MD, PhD    617-447-9707    YJIANG@PARTNERS.ORG   
Principal Investigator: Yandong Jiang, MD, PhD         
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Yandong Jiang, MD, PhD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Yandong Jiang, Assistant professor, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01516697     History of Changes
Other Study ID Numbers: 2011-P-001449
Study First Received: January 12, 2012
Last Updated: August 2, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
thoracic electric bioimpedance
cardiac output monitoring
cesarean section
spinal anesthesia

Additional relevant MeSH terms:
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014